Travatan 40 micrograms/ml eye drops solution

  • Name:

    Travatan 40 micrograms/ml eye drops solution

  • Company:
    info
  • Active Ingredients:

    Travoprost

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/01/20

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Summary of Product Characteristics last updated on medicines.ie: 29/8/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 114 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 8 January 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 29 August 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 3 September 2018 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

EPA wording and QRD template updated

Updated on 4 July 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 June 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Section 4.8 of the Travatan SmPC updated following approval of a safety variation. 

Updated on 8 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 June 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 30 May 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- sections 7,8 and 10 updated following approval of change of ownership from Alcon to Novartis.

Updated on 19 May 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 8 April 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 February 2015 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Type II resin change

Updated on 11 February 2015 PIL

Reasons for updating

  • Change of contraindications

Updated on 13 January 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Variation to extend the indiciation to ''patients form 2 months to less than 18 years of age with paediatric glaucoma or ocular hypertension''. 

Updated on 9 January 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 7 October 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Update to Irish authority contact information

Updated on 3 October 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 June 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 - Added "After cap is removed, if the tamper evident snap collar is loose, remove before using the medicinal product." and "For patients who wear contact lenses, please refer to section 4.4."

Section 4.4 - Added "Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.", "TRAVATAN should therefore be used with caution in patients with active intraocular inflammation." and "Macular oedema has been reported during treatment with prostaglandin F2a analogues."

Section 4.6 - Added fertility information

Section 4.7 - Added "
TRAVATAN has no or negligible influence on the ability to drive and use machines, however..."

Section 4.8 - Section re-formatted and revised to update to adverse events and frequency. Added reporting information

Section 6.5 - Added "Each 4 mL bottle will contain 2.5 mL of solution."

Updated on 28 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 August 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 July 2013 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 30 May 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

MAH address update

Updated on 29 May 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 4 May 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 4.8, Undesirable effects, the following changes have been made to the side effects listed for the benzalkonium preserved Travatan - 'conjunctival hyperaemia, anterior chamber flare, eye irritation, abnormal sensation in the eye, foreign body sensation in eyes, eyelid pruritus, macular degenration, iridocyclitis, iritis, anterior chamber inflammation, eye swelling, corneal staining, corneal epithelium defect, corneal pigmentation, allergic conjunctival discorder, conjunctivitis, keratoconjunctivitis sicca, pigment dispersion syndrome, eye allergy, eyelid pain, dark circles under eyes, eyelid disorder, scleral hyperaemia' are removed, and 'anterior chamber inflammation' is added.
In the side effects listed under poluquaternium-1 preserved Travatan - 'eye irritation, foreign body sensation in eyes, conjunctival hyperaemia and eyelid pruritus' are removed, and 'ocular discomfort' is added.

In Section 10, Date of revision of the text, the date of revision is updated.

Updated on 9 December 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 2, Qualitative and quantitative composition, the excipient Benzalkonium Chloride has been replaced with ‘polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg’

In Section 4.2, Posology and method of administration, ‘For Ocular use’ is moved under the sub-section ‘Method of Administration’

In Section 4.4, Special warnings and precautions for use, the warning related to Benzalkonium Chloride is replaced with the following text – ‘TRAVATAN contains propylene glycol which may cause skin irritation.’

In Section 4.8, Undesirable effects, additional information about polyquaternium-1-preserved Travatan is included.

In Section 5.1, Pharmacodynamic properties, additional information about polyquaternium-1-preserved Travatan is included.

In Section 6.1, Excipients, the list of excipients has been modified to remove ‘Benzalkonium Chloride, Trometamol and Disodium Edetate’ and add ‘Polyquaternium-1, Sodium Chloride and Propylene Glycol (E1520)’

In Section 6.3, Shelf Life, the shelf life has been changed from 3 Years to 2 Years.

In Section 9, Date of first authorisation/ Renewal of authorisation, the date of last renewal is corrected.

In Section 10, Date of revision of the text, the revision date is amended.

Updated on 9 December 2010 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 March 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8    Update of terminology

Updated on 20 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 May 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 28 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)